Manufacturers of IVD devices that will be Class D under the IVDR have one month left to appoint their Swiss Authorized Representative (CH-REP). The last date by which these products may be placed onto the market without a CH-REP is 31 December 2022.
From that appointment date, the manufacturer must identify the CH-REP on its labeling. Swissmedic has released a ‘CH-REP’ symbol for this purpose.
This requirement applies even if your device is currently self-certified under the IVDD as a ‘legacy’ device and has not yet been transitioned to the IVDR.
The deadline for IVDs which will be Class B and C under the IVDR is 31 March 2023, and the deadline for Class A is 31 July 2023.
For more information on the CH-REP labeling requirements, please read: In-country Labeling Requirements for the EU, UK, and Switzerland
For more information on the role of a CH-REP, please read: Swiss Authorized Representative